,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #edba ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #ab1 #bjai,mr4 ,luetkemey] 7= himself1 ,mrs4 ,wagn]1 ,mr4 ,clay1 ,mr4 ,smi? ( ,miss\ri1 ,mr4 ,long1 ,mr4 ,graves ( ,miss\ri1 & ,mr4 ,cleav]7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ! ,judici>y1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d ! ,controll$ ,sub/ances ,act to li/ f5tanyl-relat$ sub/ances z s*$ule ,i controll$ sub/ances4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/opp+ ,illicit ,traffick+ ,act ( #bjai or ! ,,sift ,act ( #bjai4 #b4 ,f5tanyl-relat$ sub/ances ,section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hab7 is am5d$-- 7#a7 by add+ at ! end ( subsection 7b7 ( ,s*$ule ,i ! foll[+3 7#bc7 ,isobutyryl f5tanyl4 7#bd7 ,p>a-,me?oxybutyrylf5tanyl4 7#be7 ,val]yl f5tanyl4 7#bf7 ,cyclop5tyl f5tanyl4 7#bg7 ,p>a-,*loroisobutyryl f5tanyl4 2 & 7#b7 by add+ at ! end ( ,s*$ule ,i ! foll[+3 7e7 7#a7 ,unless specifically exempt$ or unless li/$ 9 ano!r s*$ule1 any mat]ial1 comp\nd1 mixture1 or prep>ation :i* conta9s any quantity ( f5tanyl-relat$ sub/ances1 or :i* conta9s _! salts1 isom]s1 & salts ( isom]s :5ev] ! exi/5ce ( su* salts1 isom]s1 & salts ( isom]s is possible )9 ! specific *emical designation4 7#b7 ,9 p>agraph 7#a71 ! t]m f5tanyl-relat$ sub/ances includes ! foll[+3 7,a7 ,any sub/ance t is /ructurally relat$ to f5tanyl by "o or m ( ! foll[+ modifications3 7i7 ,by replacem5t ( ! ph5yl portion ( ! ph5e?yl gr\p by any monocycle1 :e!r or n fur!r sub/itut$ 9 or on ! monocycle4 7ii7 ,by sub/itution 9 or on ! ph5e?yl gr\p ) alkyl1 alk5yl1 alkoxy1 hydroxy1 halo1 haloalkyl1 am9o or nitro gr\ps4 7iii7 ,by sub/itution 9 or on ! pip]id9e r+ ) alkyl1 alk5yl1 alkoxy1 e/]1 e!r1 hydroxy1 halo1 haloalkyl1 am9o or nitro gr\ps4 7iv7 ,by replacem5t ( ! anil9e r+ ) any aromatic monocycle :e!r or n fur!r sub/itut$ 9 or on ! aromatic monocycle4 7v7 ,by replacem5t ( ! ,n-propionyl gr\p by ano!r acyl gr\p4 7,b7 #d-,me?yl acetyl f5tanyl4 7,c7 ,crotonyl f5tanyl4 7,d7 #b-;,fluoro or?o-fluor(5tanyl4 7,e7 ,or?o-,me?yl acetylf5tanyl4 7,f7 ,?i(uranyl f5tanyl4 7,g7 ,or?o-,fluorobutyryl f5tanyl4 7,h7 ,or?o-,fluoroacryl f5tanyl4 7,i7 ,beta-,me?yl f5tanyl4 7,j7 ,ph5yl f5tanyl4 7,k7 ,p>a-,me?ylf5tanyl4 7,l7 ,beta-,ph5yl f5tanyl4 7,m7 ,b5zodioxole f5tanyl4 4 #c4 ,removal f s*$ule ,i7e7 ( f5tanyl-relat$ sub/ances ,section #bja ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7k7 7#a7 ,if ! ,secret>y f9ds1 bas$ on ! factors specifi$ 9 p>agraph 7#d71 t a sub/ance li/$ 9 s*$ule ,i7e7 has no pot5tial = abuse1 ! ,secret>y %all-- 7,a7 notify ! ,attorney ,g5]al at lea/ #ij days prior to submitt+ an evaluation sci5tific & m$ical evaluation ( t sub/ance support+ t conclusion2 & 7,b7 submit to ! ,attorney ,g5]al su* evaluation & conclusion t-- 7i7 is 9 writ+2 & 7ii7 includes ! bases = su* conclusion4 7#b7 ,n lat] ?an #ij days aft] ! receipt ( su* evaluation & conclusion1 ! ,attorney ,g5]al %all issue an ord] remov+ su* sub/ance f ! s*$ule4 7#c7 7,a7 ,if ! ,secret>y f9ds1 bas$ on ! factors specifi$ 9 p>agraph 7#d71 t a sub/ance li/$ 9 s*$ule ,i7e7 does n meet ! requirem5ts = inclusion 9 t s*$ule1 & t ! sub/ance has a l[ pot5tial = abuse1 ! ,secret>y %all submit to ! ,attorney ,g5]al a sci5tific & m$ical evaluation ( t sub/ance support+ ^? conclusions t is 9 writ+ & t includes ! bases = t conclusion4 7,b7 ,)9 #ahj days ( receipt ( su* evaluation & conclusion1 ! ,attorney ,g5]al %all-- 7i7 issue an ord] remov+ su* sub/ance f s*$ul+ = rese>* purposes only1 or 7ii7 notify ! ,secret>y 9 writ+ t ! ,attorney ,g5]al decl9es to issue su* an ord]4 7#d7 ,9 mak+ ! evaluation & conclusion describ$ 9 p>agraph 7#a7 or 7#c71 ! ,secret>y-- 7,a7 %all consid] ! factors specifi$ 9 p>agraphs 7#a71 7#b71 7#c71 & 7#f7 ( subsection 7c7 & any in=mation submitt$ to ! ,attorney ,g5]al "u p>agraph 7#a7 ( ?is subsection2 & 7,b7 may also consid] factors specifi$ 9 p>agraphs 7#d71 7#e71 & 7#g7 ( subsection 7c7 if ! ,secret>y f9ds t reliable evid5ce exi/s ) respect to su* factors4 7#e7 ,no?+ 9 ?is subsection %all preclude ! ,attorney ,g5]al f transf]r+ a sub/ance li/$ 9 s*$ule ,i to ano!r s*$ule1 or remov+ su* sub/ance entirely f ! s*$ules1 pursuant to o!r provisions ( ?is section or section #bjb4 7#f7 ,a sub/ance remov$ f s*$ule ,i7e7 pursuant to p>agraph 7#a7 or 7#c7 may1 at any "t1 be controll$ pursuant to ! o!r provisions ( ?is section or section #bjb )\t reg>d to t removal4 4 #d4 ,cl>ification ( c]ta9 regi/ration requirem5ts relat$ to rese>* 7a7 ,exception = ag5ts or employees ( regi/]$ rese>*]s ,section #cjb7;c77#a7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;c77#a77 is am5d$ by /rik+ or disp5s] & ins]t+ disp5s]1 or rese>*]4 7b7 ,con=m+ am5dm5t ,section #ajb7c7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb7c77 is am5d$ by /rik+ or disp5s] & ins]t+ disp5s]1 or rese>*]4 7c7 ,s+le regi/ration = contigu\s rese>* sites ,section #cjb7;e7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;e77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,not)/&+ p>agraph 7#a71 a p]son regi/]$ to conduct rese>* ) a controll$ sub/ance "u section #cjc7;f7 may conduct su* rese>* "u a s+le regi/ration if su* rese>* occurs exclusively on a s+le1 contigu\s campus & ! regi/rant notifies ! ,attorney ,g5]al 9 writ+ ( all sites on ! campus :]e ! rese>* w be conduct$ or :]e ! controll$ sub/ance w be /or$ or adm9i/]$4 ,if ! regi/rant seeks to conduct su* rese>* at additional sites1 ! regi/rant %all submit a new notification be=e conduct+ su* rese>* at any su* additional sites4 4 7d7 ,new inspection n requir$ 9 c]ta9 situations ,section #cjc7;f7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;f77 is am5d$-- 7#a7 by /rik+ 7f7 ,! & ins]t+ 7f77#a7 ,!2 & 7#b7 by add+ a new p>agraph1 z foll[s3 7#b7 7,a7 ,if a p]son is regi/]$ to conduct rese>* ) a controll$ sub/ance & applies to be regi/]$1 or to modify a regi/ration to conduct rese>* ) a second controll$ sub/ance t is 9 ! same s*$ule or 9 a s*$ule ) a high] num]ical designation1 a new inspection by ! ,attorney ,g5]al ( ! regi/]$ location is n requir$4 7,b7 ,no?+ 9 ?is p>agraph %all prohibit ! ,attorney ,g5]al f conduct+ any inspection if ! ,attorney ,g5]al det]m9es su* an inspection is necess>y4 4 7e7 ,cont9uation ( rese>* on newly add$ sub/ances2 au?ority ,to conduct rese>* ) o!r sub/ances ,section #cjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb71 z am5d$ by subsections 7a7 & 7c71 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 7#a7 ,9 ! case ( a p]son :o is conduct+ rese>* on a sub/ance at ! "t ! sub/ance is add$ to s*$ule ,i & :o is already regi/]$ to conduct rese>* ) ano!r controll$ sub/ance 9 s*$ule ,i or ,,ii1 ! p]son-- 7,a7 )9 #cj days ( ! s*$ul+ ( su* sub/ance1 %all submit a complet$ application = regi/ration or modification ( ! exi/+ regi/ration ( su* p]son1 to conduct rese>* on su* sub/ance1 9 accordance ) ! regulations issu$ by ! ,attorney ,g5]al2 & 7,b7 not)/&+ subsections 7a7 & 7b71 may cont9ue to conduct ! rese>* on su* sub/ance until ! date on :i*-- 7i7 ! application ref]r$ to 9 subp>agraph 7,a7 is )drawn by ! applicant2 or 7ii7 ! ,attorney ,g5]al s]ves on ! applicant an ord] to %[ cause propos+ ! d5ial ( ! application pursuant to section #cjd7;c74 7#b7 ,if ! ,attorney ,g5]al s]ves an ord] to %[ cause "u p>agraph 7#a77;,b7 & ! applicant reque/s a he>+1 su* he>+ %all be held-- 7,a7 on an exp$it$ basis2 & 7,b7 n lat] ?an #de days aft] ! reque/ is made1 or su* a lat] "t z reque/$ by ! applicant4 7#c7 7,a7 ,a p]son :o is regi/]$ to conduct rese>* ) a controll$ sub/ance 9 s*$ule ,i may1 not)/&+ subsections 7a7 & 7b71 conduct rese>* ) ano!r controll$ sub/ance 9 s*$ule ,i1 if ea* ( foll[+ conditions are met3 7i7 ,! p]son has appli$ = a modification ( ! p]son's regi/ration to au?orize rese>* ) su* o!r controll$ sub/ance 9 accordance ) ! regulations issu$ by ! ,attorney ,g5]al4 7ii7 ,! ,attorney ,g5]al has obta9$ v]ification f ! ,secret>y t ! rese>* protocol submitt$ ) ! application is m]itori\s4 7iii7 ,! ,attorney ,g5]al has det]m9$ "u subp>agraph 7,b7 t ! conduct ( su* rese>* is consi/5t ) ,unit$ ,/ates obligations "u ! ,s+le ,conv5tion on ,n>cotic ,drugs1 #aifa4 7,b7 ,n lat] ?an #cj days aft] receiv+ an application "u clause 7i71 ! ,attorney ,g5]al %all det]m9e :e!r ! conduct ( rese>* t is ! subject ( ! application is consi/5t ) ,unit$ ,/ates obligations "u ! ,s+le ,conv5tion on ,n>cotic ,drugs1 #aifa4 7,c7 ,no?+ 9 ?is section %all be con/ru$ to alt] ! au?ority ( ! ,attorney ,g5]al to initiate proce$+s to d5y1 susp5d1 or revoke any regi/ration 9 accordance ) sections #cjc & #cjd4 4 7f7 ,treatm5t ( c]ta9 activities z co9cid5t to rese>* ,section #cjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb71 z am5d$ by subsections 7a71 7c71 & 7e71 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,a p]son :o is regi/]$ to p]=m rese>* ) a controll$ sub/ance 7o!r ?an m>ihuana7 "u ?is title may1 )\t be+ requir$ to regi/]$ to manufacture su* sub/ance1 us+ small quantities ( su* sub/ance1 p]=m ! foll[+ activities3 7#a7 ,process+ ! sub/ance to create extracts1 t9ctures1 oils1 solutions1 d]ivatives1 or o!r =ms ( ! sub/ance consi/5t ) ! approv$ rese>* protocol4 7#b7 ,dosage =m developm5t = ! purpose ( satisfy+ requirem5ts ) respect to ! submission ( an inve/igational new drug application "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 #e4 ,review ( rese>* regi/ration process 7a7 ,review ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is section1 ! ,attorney ,g5]al & ! ,secret>y ( ,heal? & ,human ,s]vices %all jo9tly conduct a review ( ! processes us$ to regi/] or modify a regi/ration to conduct rese>* ) controll$ sub/ances "u ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq471 includ+-- 7#a7 an evaluation ( ! impacts ( ! am5dm5ts made by ?is ,act on ! risk ( ! div]sion ( controll$ sub/ances us$ 9 rese>* & relat$ public safety consid]ations2 & 7#b7 an id5tification ( opportunities to r$uce any unnecess>y burd5 on p]sons seek+ regi/ration1 pot5tial r$undancies1 & ineffici5cies 9 su* processes1 includ+-- 7,a7 ! process = obta9+ a regi/ration "u section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc72 & 7,b7 ! process by :i* ! ,secret>y reviews rese>* protocols submitt$ ) respect to su* regi/ration4 7b7 ,guidance ,n lat] ?an #fj days aft] conclud+ ! review describ$ 9 subsection 7a71 ! ,attorney ,g5]al & ! ,secret>y %all1 z appropriate1 jo9tly issue guidance to regi/rants & pot5tial regi/rants cl>ify+ ! process = regi/ration4